COVERSYL PLUS Tablet Ref.[50551] Active ingredients: Indapamide Perindopril

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2020  Publisher: Servier Laboratories South Africa (Pty) Ltd, Building Number 4, Country Club Estate, 21 Woodlands Drive, Woodmead, 2191

4.1. Therapeutic indications

Coversyl Plus is indicated for the treatment of essential hypertension, in patients where blood pressure is not adequately controlled and where fixed combination is considered more appropriate than monotherapy.

4.2. Posology and method of administration

Posology

The dosage regimen depends upon the individual requirements of the patient and is at the discretion of the medical doctor. One Coversyl Plus tablet per day as a single dose, preferably to be taken in the morning before a meal.

Special populations

Elderly (see section 4.4)

It is recommended to start the treatment with only one of the constituents.

Patients with renal failure (see section 4.4)

In cases of severe renal failure (creatinine clearance below 30 ml/min), treatment is contra-indicated. In patients with a creatinine clearance greater than or equal to 30 ml/min and less than 60 ml/min, it is recommended to start the treatment with only one of the constituents. It is not necessary to change the dose when the creatinine clearance is greater than 60 ml/min.

Method of administration

Oral use.

4.9. Overdose

The most likely adverse event in case of overdose is hypotension, sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion, oliguria, which may progress to anuria (due to hypovolaemia). Salt and water disturbances (low sodium levels, low potassium levels) may occur.

The first measures to be taken consist of rapidly eliminating the product(s) ingested by gastric lavage and/or administration of activated charcoal, then restoring fluid and electrolyte balance in a specialised centre until they return to normal.

If marked hypotension occurs, this can be treated by placing the patients in a supine position with the head lowered. If necessary an IV infusion of isotonic saline may be given, or any other method of volaemic expansion may be used. Perindoprilat, the active form of perindopril, can be dialysed.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store at or below 25°C in a dry place.

6.5. Nature and contents of container

Blister packs of clear PVC and Aluminium with 30 tablets in a carton.

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